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NCT07332013 · ClinicalTrials.gov registry record · NA
Urinary Titin Biomarker in DMD
A NA study of Duchenne Muscular Dystrophy (DMD) and Becker's Muscular Dystrophy (BMD), sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07332013: Recruiting NA study of Duchenne Muscular Dystrophy (DMD) and Becker's Muscular Dystrophy (BMD), sponsored by Children's Hospital of Philadelphia.
NCT07332013 is a NA study of Duchenne Muscular Dystrophy (DMD) and Becker's Muscular Dystrophy (BMD) that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 50 participants, below the 87-participant average among 3 other Duchenne Muscular Dystrophy (DMD) trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07332013, a NA study of Duchenne Muscular Dystrophy (DMD) and Becker's Muscular Dystrophy (BMD), is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
A universal challenge in clinical investigation of novel therapeutics is the need for quantitative, objective biomarkers that directly address the mechanisms of disease and provide information relevant to clinically meaningful functional improvement. This has been a particular challenge in rare and slowly progressive diseases such as Duchenne Muscular Dystrophy (DMD). The investigators hypothesize that urinary N-terminal fragment of titin (NTFT) corresponding to activity level/intensity will define a high-precision, non-invasive biomarker of systemic muscle injury to enable serial measurements of efficacy and safety in the clinical investigation of gene therapy for DMD and other myopathies. This should provide a valuable exploratory, secondary and eventually primary outcome measure of therapeutic efficacy to minimize the enrollment size in informative early phase and pivotal clinical trials.
Primary Outcome
Change in urinary NTFT concentration will be measured before and after clinical visits, during which subjects will complete standard of care physical therapy assessments and perform a two-flight stair descent (if able).
Conditions Studied
Interventions
- OTHER Descending stair walk
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2029-12 |
| Phase | NA |
What NCT07332013 shows while recruiting
NCT07332013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 87-participant average among 3 other Duchenne Muscular Dystrophy (DMD) trials with a reported enrollment target (43% lower).
The record links to 2 conditions, with Duchenne Muscular Dystrophy (DMD) appearing as the primary indexed condition, and to 1 intervention - of which Descending stair walk is the first listed.
NCT07332013 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07332013 about?
NCT07332013 is a clinical study titled "Urinary Titin Biomarker in DMD". A universal challenge in clinical investigation of novel therapeutics is the need for quantitative, objective biomarkers that directly address the mechanisms of disease and provide information relevant to clinically meaningful functional improvement. This has been a particular challenge in rare and ...
What is the current status of trial NCT07332013?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2026-03-01. Estimated completion is 2029-12.
What conditions does trial NCT07332013 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy (DMD), Becker's Muscular Dystrophy (BMD).
What interventions are being tested in trial NCT07332013?
The interventions under investigation include: Descending stair walk (OTHER).
Who is sponsoring clinical trial NCT07332013?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07332013 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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